Principal Design Quality Assurance Engineer, Clinical
2 months ago
We are seeking a highly experienced Principal Design Quality Assurance Engineer, Clinical to join our team at Waters Corporation. As a key member of our quality assurance team, you will be responsible for ensuring the design and development of our clinical products meet the highest standards of quality and regulatory compliance.
Key Responsibilities- Regulatory Compliance: Assume a Subject Matter Expert (SME) role on Product Development process activities and related workflows in relation to regulatory compliance, providing 'solution-based' problem resolution.
- Quality Assurance: Act as Quality specialist in relation to design and development, ensuring conformance and up-to-date information on applicable regulatory requirements, including ISO 9001; ISO 13485; 21 CFR parts 11 and 820, ISO 62304, ISO 62366, ISO 14971.
- Mentorship: Mentor to Design Quality Engineers, Clinical on design control requirements and approach.
- Process Improvement: Provide interpretation guidance and mentorship on industry best practice deploying new, or changes to existing, processes and systems to improve the overall effectiveness, efficiency and compliance of the quality management system.
- Product Evaluation: Evaluate the acceptability of products for release, ensuring customer requirements/specifications and internal Waters policies and procedures are met.
- Leadership: Provide leadership and direction on all quality activities necessary for the design quality to achieve design control deliverables, specifically deliverables related to product safety, usability, risk management, compliance, product performance and registration.
- Collaboration: Actively participate in and/or facilitate the development, review and approval of requirements and deliverables required to support product development (planning, requirements, architecture, verification/validation including risk management, maintenance, configuration management and problem resolution.
- Education: Minimum of a Bachelors Degree required. Chemistry, Medical or Science Graduate education is preferable.
- Experience: Extensive demonstrable experience of leading quality assurance activities supporting product development in a medical device environment - ISO 13485, ISO 14971, ISO 62304, ISO 62366 and applicable good manufacturing practice regulations including, 21 CFR part 820.
- Skills: Strong leadership, coaching and mentoring skills. Strong ability to lead staff dispersed across many different locations and cultures. Strong organization/prioritization skills. Exceptional interpersonal skills using written and oral communication are required, for example to ensure succinct report generation, effective communication with stakeholders, peer groups etc. across organization. Strong analytical skills with the ability to identify, diagnose, and solve problems with minimal direction and make decisions with confidence.
-
Principal Design Quality Engineer Clinical
4 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob Title: Principal Design Quality Engineer, ClinicalWaters Corporation, a leading specialty measurement company, is seeking a Principal Design Quality Engineer, Clinical to join our team. This role will be based in Wilmslow, Manchester or Wexford, Ireland, with a hybrid work schedule.Job Summary:The Principal Design Quality Engineer, Clinical will be...
-
Principal Design Quality Engineer Clinical
4 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob Title: Principal Design Quality Engineer, ClinicalWaters Corporation, a leading specialty measurement company, is seeking a Principal Design Quality Engineer, Clinical to join our team. This role will be based in Wilmslow, Manchester or Wexford, Ireland, with a hybrid work schedule.Job Summary:The Principal Design Quality Engineer, Clinical will be...
-
Principal Design Quality Engineer Clinical
4 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob Title: Principal Design Quality Engineer, ClinicalAbout the Role:We are seeking a highly experienced Principal Design Quality Engineer, Clinical to join our team at Waters Corporation. As a key member of our quality assurance team, you will be responsible for ensuring the design and development of our medical devices meet the highest standards of quality...
-
Principal Design Quality Engineer Clinical
4 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob Title: Principal Design Quality Engineer, ClinicalAbout the Role:We are seeking a highly experienced Principal Design Quality Engineer, Clinical to join our team at Waters Corporation. As a key member of our quality assurance team, you will be responsible for ensuring the design and development of our medical devices meet the highest standards of quality...
-
Principal Design Quality Engineer, Clinical Lead
3 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob SummaryWe are seeking a highly experienced Principal Design Quality Engineer, Clinical to join our team at Waters Corporation. This role will be responsible for leading the development of clinical design quality assurance processes and procedures to ensure compliance with regulatory standards and company policies.The successful candidate will have...
-
Principal Design Quality Engineer, Clinical Lead
3 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob SummaryWe are seeking a highly experienced Principal Design Quality Engineer, Clinical to join our team at Waters Corporation. This role will be responsible for leading the development of clinical design quality assurance processes and procedures to ensure compliance with regulatory standards and company policies.The successful candidate will have...
-
Principal Design Quality Engineer, Clinical
2 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob SummaryWaters Corporation is seeking a Principal Design Quality Engineer, Clinical to join our team. As a key member of our Clinical Design Quality team, you will be responsible for ensuring the development of all new IVD products complies with applicable regulatory standards and systems.Key ResponsibilitiesEvaluate the acceptability of products for...
-
Principal Design Quality Engineer Clinical
3 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob Title: Principal Design Quality Engineer, ClinicalWaters, a leading specialty measurement company, is seeking a Principal Design Quality Engineer, Clinical to join our team. This role will be based in Wilmslow, Manchester or Wexford, Ireland, with a hybrid work schedule.Job Summary:The Principal Design Quality Engineer, Clinical will provide support and...
-
Principal Design Quality Engineer Clinical
3 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob Title: Principal Design Quality Engineer, ClinicalWaters, a leading specialty measurement company, is seeking a Principal Design Quality Engineer, Clinical to join our team. This role will be based in Wilmslow, Manchester or Wexford, Ireland, with a hybrid work schedule.Job Summary:The Principal Design Quality Engineer, Clinical will provide support and...
-
Principal Design Quality Engineer, Clinical
2 months ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob SummaryWe are seeking a highly skilled Principal Design Quality Engineer, Clinical to join our team at Waters Corporation. As a key member of our Clinical Design Quality team, you will be responsible for ensuring the development of all new IVD products complies with applicable regulatory standards and systems.Key ResponsibilitiesAssume a Subject Matter...
-
Principal Design Quality Engineer, Clinical
2 months ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob SummaryWe are seeking a highly skilled Principal Design Quality Engineer, Clinical to join our team at Waters Corporation. As a key member of our Clinical Design Quality team, you will be responsible for ensuring the development of all new IVD products complies with applicable regulatory standards and systems.Key ResponsibilitiesAssume a Subject Matter...
-
Principal Design Quality Engineer Clinical
1 month ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob Title: Principal Design Quality Engineer, ClinicalOverviewWaters Corporation, a leading specialty measurement company, is seeking a Principal Design Quality Engineer, Clinical to join our team. This role will be based in Wilmslow, Manchester or Wexford, Ireland, with a hybrid work schedule (two to three days per week on-site).The Clinical Design Quality...
-
Principal Design Quality Engineer Clinical
1 month ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob Title: Principal Design Quality Engineer, ClinicalOverviewWaters Corporation, a leading specialty measurement company, is seeking a Principal Design Quality Engineer, Clinical to join our team. This role will be based in Wilmslow, Manchester or Wexford, Ireland, with a hybrid work schedule (two to three days per week on-site).The Clinical Design Quality...
-
Principal Design Quality Engineer Clinical
1 month ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob SummaryWaters, a leading global specialty measurement company, is seeking a Principal Design Quality Engineer Clinical to join our team. This role will be based in Wilmslow, Manchester or Wexford, Ireland, with a hybrid work schedule.The successful candidate will be responsible for supporting the development of new IVD products, ensuring compliance with...
-
Principal Design Quality Engineer Clinical
1 month ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob SummaryWaters, a leading global specialty measurement company, is seeking a Principal Design Quality Engineer Clinical to join our team. This role will be based in Wilmslow, Manchester or Wexford, Ireland, with a hybrid work schedule.The successful candidate will be responsible for supporting the development of new IVD products, ensuring compliance with...
-
Principal Design Quality Engineer Clinical
1 month ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob SummaryWaters, a leading global specialty measurement company, is seeking a Principal Design Quality Engineer Clinical to join our team. This role will be based in Wilmslow, Manchester or Wexford, Ireland, with a hybrid work schedule.The successful candidate will be responsible for supporting the development of new IVD products, ensuring compliance with...
-
Principal Design Quality Engineer Clinical
1 month ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob SummaryWaters, a leading global specialty measurement company, is seeking a Principal Design Quality Engineer Clinical to join our team. This role will be based in Wilmslow, Manchester or Wexford, Ireland, with a hybrid work schedule.The successful candidate will be responsible for supporting the development of new IVD products, ensuring compliance with...
-
Principal Design Quality Engineer Clinical
1 month ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob SummaryWaters, a leading global specialty measurement company, is seeking a Principal Design Quality Engineer Clinical to join our team. This role will be based in Wilmslow, Manchester or Wexford, Ireland, with a hybrid work schedule (two to three days per week on-site).The successful candidate will be responsible for supporting the development of all...
-
Principal Design Quality Engineer Clinical
1 month ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob SummaryWaters, a leading global specialty measurement company, is seeking a Principal Design Quality Engineer Clinical to join our team. This role will be based in Wilmslow, Manchester or Wexford, Ireland, with a hybrid work schedule (two to three days per week on-site).The successful candidate will be responsible for supporting the development of all...
-
Principal Design Quality Engineer Clinical
2 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob OverviewWe are seeking a highly skilled Principal Design Quality Engineer, Clinical to join our team at Waters Corporation. This role will be based in Wilmslow, Manchester or Wexford, Ireland, with a hybrid work schedule of two to three days per week on-site.The successful candidate will be responsible for supporting the development of all new IVD...
